GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF

NCT ID: NCT00336336

Last Updated: 2015-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

6975 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2008-05-31

Brief Summary

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INTRODUCTION While pharmacological treatments specifically targeted to the cardio-circulatory system have been largely investigated, scanty controlled data are available concerning the role of dietary and metabolic approaches in the management/outcome of patients with heart failure. A large scale, randomized, clinical trial is proposed to test the effects of (a) n-3 PUFA and (b) a lipid lowering agent on top of the best recommended treatments for heart failure.

STUDY DESIGN

The GISSI-HF is a prospective, multicenter, randomized, double blind, placebo controlled study, with randomized allocation of patients with a clinical diagnosis of heart failure to:

Randomization 1 (R1): n-3 PUFA 1 g daily vs corresponding placebo; Randomization 2 (R2): rosuvastatin 10 mg daily vs corresponding placebo.

OBJECTIVES OF THE STUDY PRIMARY OBJECTIVES

To demonstrate that, in patients with heart failure treated at the best of recommended therapies, long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than the corresponding placebo in the reduction of:

* All-cause mortality
* All-cause mortality or hospitalizations for cardiovascular reason

OTHER END-POINT MEASURES OF EFFICACY

To assess that long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than corresponding placebo in the reduction of:

* Cardiovascular mortality
* Cardiovascular mortality or hospitalizations for any reason
* Sudden cardiac death
* Hospitalizations for any reason
* Hospitalizations for cardiovascular reasons
* Hospitalizations for congestive heart failure
* Myocardial infarction
* Stroke

Detailed Description

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The Protocol is sponsored by an independent organization and partially supported by: AstraZeneca, Società Prodotti antibiotici, Sigma Tau, Pfizer

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

N-3PUFA

Group Type EXPERIMENTAL

n-3 PUFA

Intervention Type DRUG

1 g die per os

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 gram c. per os

3

Rosuvastatin

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

10 mg die per os

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

10 mg c. per os

Interventions

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n-3 PUFA

1 g die per os

Intervention Type DRUG

Rosuvastatin

10 mg die per os

Intervention Type DRUG

Placebo

1 gram c. per os

Intervention Type DRUG

Placebo

10 mg c. per os

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical evidence of heart failure according to the European Society of Cardiology guidelines (New York Heart Association class II-IV) (32)
* Any left ventricular Ejection Fraction (EF) measured within 3 months from enrolment (if EF% \>40%, at least 1 hospital admission for Congestive Heart Failure(CHF) in the previous year)
* No age limits
* Any etiology
* Informed consent (obtained before any study specific procedure)

Exclusion Criteria

* Acute Myocardial Infarction, unstable angina or revascularization procedure within 1 month;
* planned cardiac surgery, expected to be performed within 3 months;
* congenital or primary valvular etiology;
* known hypersensitivity to study treatments;
* significant liver disease;
* pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception;
* any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol;
* presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy;
* treatment with any investigational agent within 1 month before randomization;
* patients already on treatment with n-3 PUFA or statin for whom the prescription is confirmed.


* current serum creatinine level \>2.5 mg/dL;
* current ALT, AST level \>1.5 times the upper normal limit;
* current CPK upper normal limits.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo di Ricerca GISSI

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luigi Tavazzi, MD

Role: STUDY_CHAIR

Policlinico San Matteo di Pavia

Gianni Tognoni, MD

Role: STUDY_CHAIR

Consorzio Mario Negri Sud

Locations

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Ospedale San Giovanni di Dio

Agrigento, AG, Italy

Site Status

Ospedale Barone Lombardo

Canicattì, AG, Italy

Site Status

Ospedale San Giacomo D'Altopasso

Licata, AG, Italy

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Ospedale Civile

Acqui Terme, AL, Italy

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Ospedale San Giacomo

Novi Ligure, AL, Italy

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Presidio Cardiologico G.M. Lancisi

Ancona, AN, Italy

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Ospedale Generale Regionale

Aosta, AO, Italy

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Osp. Gen.le Prov.le C.G.Mazzoni

Ascoli Piceno, AP, Italy

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Ospedale Civile Augusto Murri

Fermo, AP, Italy

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Ospedale Madonna del Soccorso

San Benedetto del Tronto, AP, Italy

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Ospedale Civile SS.Filippo e Nicola

Avezzano, AQ, Italy

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Presidio Ospedaliero San Salvatore

L’Aquila, AQ, Italy

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Ospedale San Donato

Arezzo, AR, Italy

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Ospedale Valdichiana Santa Margherita

Cortona, AR, Italy

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Osp.Valdarno "S.Maria della Gruccia"

Montevarchi, AR, Italy

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Ospedale Cardinal Massaia

Asti, AT, Italy

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Ospedale San Paolo

Bari, BA, Italy

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Ospedale Consorziale Policlinico

Bari, BA, Italy

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Ospedale di Venere

Bari - Carbonara, BA, Italy

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Ospedale Monsignor Angelo R. di Miccoli

Barletta, BA, Italy

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Fondazione S. Maugeri Clinica del Lavoro

Cassano delle Murge, BA, Italy

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IRCCS Saverio De Bellis

Castellana Grotte, BA, Italy

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Ospedale Santa Maria degli Angeli

Putignano, BA, Italy

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Ospedali Riuniti di Bergamo

Bergamo, BG, Italy

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Ospedale Bolognini

Seriate, BG, Italy

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Presidio Gazzaniga c/o Osp. Seriate

Seriate, BG, Italy

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Ospedali Riuniti di Treviglio

Treviglio, BG, Italy

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Ospedale Civile

Agordo, BL, Italy

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Ospedale Civile

Belluno, BL, Italy

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Ospedale Civile del Cadore

Pieve di Cadore, BL, Italy

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Ospedale Dossetti

Bazzano, BO, Italy

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Ospedale di Bentivoglio

Bentivoglio, BO, Italy

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Ospedale Policlinico S.Orsola-M.Malpighi

Bologna, BO, Italy

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Ospedale Bellaria

Bologna, BO, Italy

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Ospedale Civile Simiani

Loiano, BO, Italy

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Ospedale Umberto I

Fasano, BR, Italy

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Ospedale Civile Dario Camberlingo

Francavilla Fontana, BR, Italy

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Ospedale N. Melli

San Pietro Vernotico, BR, Italy

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Spedali Civili

Brescia, BS, Italy

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Ospedale Civile Mellini

Chiari, BS, Italy

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Azienda Ospedaliera

Desenzano del Garda, BS, Italy

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Presidio Ospedaliero

Gavardo, BS, Italy

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Ospedale di Manerbio

Manerbio, BS, Italy

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Ospedale Generale Provinciale

Merano, BZ, Italy

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Osedale A. Businco

Cagliari, CA, Italy

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Presidio Ospedaliero SS. Trinita'

Cagliari, CA, Italy

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Ospedale Marino

Cagliari, CA, Italy

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Azienda Osped. G.Brotzu-S.Michele (S.S.D.coord.Scompenso)

Cagliari, CA, Italy

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Azienda Ospedaliera G. Brotzu - S. Michele

Cagliari, CA, Italy

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Universita'

Cagliari-Monserrato, CA, Italy

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Ospedale Civile G. Vietri

Larino, CB, Italy

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Ospedale San Timoteo

Termoli, CB, Italy

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Presidio Ospedaliero Moscati

Aversa, CE, Italy

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Az. Ospedaliera S.Anna e S.Sebastiano

Caserta, CE, Italy

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Azienda Ospedaliera Sant'Anna e San Sebastiano

Caserta, CE, Italy

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P.O. Marcianese ASL Caserta 1

Marcianise, CE, Italy

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Ospedale Civile Ave Gratia Plena

Piedimonte Matese, CE, Italy

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Ospedale Ave Gratia Plena

San Felice A Cancello, CE, Italy

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Ospedale Renzetti

Lanciano, CH, Italy

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Ospedale San Pio da Pietrelcina

Vasto, CH, Italy

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Ospedale Civile San Lazzaro

Alba, CN, Italy

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Ospedale Maggiore SS. Trinita'

Fossano, CN, Italy

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Ospedale Civile Saluzzo

Saluzzo, CN, Italy

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Ospedale Generale di Zona Valduce

Como, CO, Italy

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Ospedale S. Anna

Como, CO, Italy

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A.O. S. Anna-Presidio di Mariano Comense

Mariano Comense, Co, Italy

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Ospedale di Menaggio

Menaggio, CO, Italy

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Ospedale Civile Oglio Po

Casalmaggiore, CR, Italy

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Istituti Ospitalieri di Cremona

Cremona, CR, Italy

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Ospedale Santa Marta

Rivolta d'Adda, CR, Italy

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Ospedale V. Cosentino

Cariati, CS, Italy

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Ospedale Civile Ferrari

Castrovillari, CS, Italy

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Ospedale Civile Guido Compagna

Corigliano Calabro, CS, Italy

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INRCA Istituto Cardiovasculop.Senili

Cosenza, CS, Italy

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Ospedale Santissima Annunziata

Cosenza, CS, Italy

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Presidio Ospedaliero Mariano Santo

Cosenza, CS, Italy

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Ospedale Civile Minervini

Mormanno, CS, Italy

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Ospedale San Francesco di Paola

Paola, CS, Italy

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Ospedale Santa Barbara

Rogliano, CS, Italy

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Ospedale Civile N. Giannettasio

Rossano, CS, Italy

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Ospedale Civile G. Chidichimo

Trebisacce, CS, Italy

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Ospedale Generale Provinciale Gravina

Caltagirone, CT, Italy

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Ospedale Garibaldi - Nesima

Catania, CT, Italy

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Ospedale Garibaldi-Nesima

Catania, CT, Italy

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Ospedale Ferrarotto

Catania, CT, Italy

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Ospedale Garibaldi - Centro

Catania, CT, Italy

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Ospedale Vittorio Emanuele II

Catania, CT, Italy

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Ospedale Cannizzaro (U.O.Cardiologia)

Catania, CT, Italy

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Ospedle Cannizzaro (UTIC)

Catania, CT, Italy

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Azienda Ospedaliera Mater Domini

Catanzaro, CZ, Italy

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Ospedale Civile Pugliese

Catanzaro, CZ, Italy

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Azienda Ospedaliera Mater Domini

Località Germaneto - Catanzaro, CZ, Italy

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Ospedale G. Basilotta

Nicosia, EN, Italy

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Ospedale M. Chiello

Piazza Armerina, EN, Italy

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Ospedale M. Bufalini-G. Marconi

Cesena, FC, Italy

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Ospedale M.Bufalini-G.Marconi

Cesenatico, FC, Italy

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Ospedale G.B.Morgagni-L.Pierantoni

Forlì, FC, Italy

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Arcispedale Sant'Anna

Ferrara, FE, Italy

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Ospedale del Delta

Lagosanto, FE, Italy

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Ospedale Civile Giuseppe Tatarella

Cerignola, FG, Italy

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Ospedali Riuniti

Foggia, FG, Italy

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Ospedale San Camillo De Lellis

Manfredonia, FG, Italy

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Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, FG, Italy

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Ospedale Santa Maria Annunziata

Bagno a Ripoli, FI, Italy

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Presidio Ospedaliero del Mugello

Borgo San Lorenzo, FI, Italy

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Ospedale Civile San Giuseppe

Empoli, FI, Italy

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Ospedale Santa Maria Nuova

Florence, FI, Italy

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Presidio Ospedaliero di Camerata

Florence, FI, Italy

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Az. Ospedaliero-Universitaria Careggi

Florence, FI, Italy

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Az. Ospedaliero-Universitaria Careggi

Florence, FI, Italy

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Az. Ospedaliero-Universitaria Careggi

Florence, FI, Italy

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Nuovo Ospedale San Giovanni di Dio

Florence, FI, Italy

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Ospedale San Pietro Igneo

Fucecchio, FI, Italy

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Ospedale Santa Scolastica

Cassino, FR, Italy

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Ospedale Civile SS. Trinita'

Sora, FR, Italy

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Dimi-Disem

Genova, GE, Italy

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Ospedali Civili di Sampierdarena

Genova-Sampierdarena, GE, Italy

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Ospedale Padre Antero Micone

Genova-Sestri Ponente, GE, Italy

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Ospedale Sestri Levante

Sestri Levante, GE, Italy

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Presidio Ospedaliero di Gorizia

Gorizia, GO, Italy

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Ospedale della Misericordia

Grosseto, GR, Italy

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Ospedale S.Andrea-Alta Maremma

Massa Marittima, GR, Italy

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Ospedale San Giovanni di Dio

Orbetello, GR, Italy

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Presidio Ospedaliero

Sanremo, IM, Italy

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Ospedale F. Veneziale

Isernia, IS, Italy

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Ospedale Civile San Giovanni di Dio

Crotone, KR, Italy

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Ospedale di Mesoraca

Mesoraca, KR, Italy

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Ospedale Umberto I

Lecco, LC, Italy

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Presidio Ospedaliero F. Ferrari

Casarano, LE, Italy

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Ospedale Santa Caterina Novella

Galatina, LE, Italy

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Ospedale Civile Sacro Cuore di Gesu'

Gallipoli, LE, Italy

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Ospedale Vito Fazzi

Lecce, LE, Italy

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Presidio Osped. Pneumologico Galateo

San Cesario di Lecce, LE, Italy

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Ospedale Ignazio Veris Delli Ponti

Scorrano, LE, Italy

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Ospedale Cardinale Panico

Tricase, LE, Italy

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Ospedale Civile Bassa Val di Cecina

Cecina, LI, Italy

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Ospedali Riuniti

Livorno, LI, Italy

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Ospedale Villamarina

Piombino, LI, Italy

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Ospedale del dono Svizzero

Formia, LT, Italy

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Ospedale Civile

Gaeta, LT, Italy

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Ospedale S. Maria Goretti

Latina, LT, Italy

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Ospedale Generale di Zona

Minturno, LT, Italy

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Ospedale Civile

Terracina, LT, Italy

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Ospedale Santa Croce

Castelnuovo Garfagnana, LU, Italy

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Nuovo Ospedale Versilia

Lido di Camaiore, LU, Italy

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Ospedale Santa Maria della Pieta'

Camerino, MC, Italy

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Ospedale Generale Provinciale

Macerata, MC, Italy

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Nuovo Pres.Osp. Cutroni Zodda

Barcellona Pozzo di Gotto, ME, Italy

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Ospedale Papardo

Messina, ME, Italy

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Ospedale Civile

Milazzo, ME, Italy

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Ospedale Barone Romeo

Patti, ME, Italy

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P.O. Sant'Agata di Militello

Sant'Agata di Militello, ME, Italy

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Presidio Ospedaliero San Vincenzo

Taormina, ME, Italy

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Ospedale di Cernusco sul Naviglio

Cernusco sul Naviglio, MI, Italy

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Ospedale Carlo Borella

Giussano, MI, Italy

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Ospedale Civile

Legnano, MI, Italy

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Ospedale Fatebenefratelli

Milan, MI, Italy

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Ospedale Maggiore Policlinico

Milan, MI, Italy

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Centro Cardiologico Monzino

Milan, MI, Italy

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Ospedale San Paolo

Milan, MI, Italy

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Ospedale San Carlo Borromeo

Milan, MI, Italy

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Ospedale Niguarda-Villa Marelli

Milan, MI, Italy

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Ospedale Niguarda

Milan, MI, Italy

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Ospedale San Gerardo

Monza, MI, Italy

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Policlinico di Monza

Monza, MI, Italy

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Presidio Ospedaliero di Passirana

Passirana-Rho, MI, Italy

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Ospedale di Sesto San Giovanni

Sesto San Giovanni, MI, Italy

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Presidio Ospedaliero

Vimercate, MI, Italy

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Ospedale di Vizzolo Predabissi

Vizzolo Predabissi, MI, Italy

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Ospedale San Pellegrino

Castiglione delle Stiviere, MN, Italy

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Presidio Ospedaliero C. Poma

Mantova, MN, Italy

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Ospedali Destra Secchia

Pieve di Coriano, MN, Italy

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Ospedale Policlinico

Modena, MO, Italy

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Presidio Ospedaliero

Pavullo nel Frignano, MO, Italy

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Nuovo Ospedale Civile di Sassuolo

Sassuolo, MO, Italy

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Civico Ospedale Carrara

Carrara, MS, Italy

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IFC CNR-Ospedale Pasquinucci

Massa, MS, Italy

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Ospedale SS.Giacomo e Cristoforo

Massa, MS, Italy

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Ospedale Madonna delle Grazie

Matera, MT, Italy

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Ospedale Civile

Policoro, MT, Italy

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Ospedale San Francesco

Nuoro, NU, Italy

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Fondazione San Raffaele G. Giglio

Cefalù, PA, Italy

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Ospedale Buccheri La Ferla Fatebenefratelli

Palermo, PA, Italy

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A.R.N.A.S. Ospedale Civico e Benfratelli

Palermo, PA, Italy

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Ospedale G.F. Ingrassia

Palermo, PA, Italy

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Ospedale G.F. Ingrassia

Palermo, PA, Italy

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Az. Osp. Villa Sofia CTO (Cardiologia II)

Palermo, PA, Italy

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Ospedale V. Cervello

Palermo, PA, Italy

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Presidio Ospedaliero Villa Sofia

Palermo, PA, Italy

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Ospedale Pubblico S. Cimino

Termini Imerese, PA, Italy

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Ospedale di Camposampiero

Camposampiero, PD, Italy

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Ospedale di Cittadella

Cittadella, PD, Italy

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Ospedale Generale Provinciale

Este, PD, Italy

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Ospedale Civile San Massimo

Penne, PE, Italy

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Ospedale Civile dello Spirito Santo

Pescara, PE, Italy

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Ospedale Alta Valle del Tevere

Città di Castello, PG, Italy

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Nuovo Ospedale San Giovanni Battista

Foligno, PG, Italy

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Ospedale Gubbio-Gualdo Tadino

Gubbio, PG, Italy

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Centro Osp.Riabilit.Intensiva (CORI)

Passignano sul Trasimeno, PG, Italy

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Presidio Ospedaliero

Todi, PG, Italy

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Azienda Ospedaliera S. Maria degli Angeli

Pordenone, PN, Italy

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Ospedale Civile

San Vito al Tagliamento, PN, Italy

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Ospedale Misericordia e Dolce

Prato, PO, Italy

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Ospedale Civile

Fidenza, PR, Italy

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Az. Ospedaliera Universitaria di Parma

Parma, PR, Italy

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Ospedale Santa Maria della Misericordia

Urbino, PU, Italy

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Ospedale San Martino

Mede, PV, Italy

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Fondazione S.Maugeri Clinica del Lavoro

Montescano, PV, Italy

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IRCCS - Fondazione Salvatore Maugeri

Pavia, PV, Italy

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Ospedale Policlinico San Matteo IRCCS

Pavia, PV, Italy

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Istituto Clinico Beato Matteo

Vigevano, PV, Italy

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Ospedale Civile

Vigevano, PV, Italy

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Ospedale Civile

Voghera, PV, Italy

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Ospedale Generale di Zona

Lagonegro, PZ, Italy

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Azienda Ospedaliera San Carlo

Potenza, PZ, Italy

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Ospedale San Francesco

Venosa, PZ, Italy

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Villa Maria Cecilia Hospital

Cotignola, RA, Italy

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Policlinico Madonna della Consolazione

Reggio Calabria, RC, Italy

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Ospedale Scillesi D'America

Scilla, RC, Italy

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Ospedale Scillesi D'America

Scilla, RC, Italy

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Ospedale Sant'Anna

Castelnovo ne' Monti, Re, Italy

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Ospedale Civile San Sebastiano

Correggio, RE, Italy

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Ospedale Civile

Ragusa, RG, Italy

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Ospedale M.P. Arezzo

Ragusa, RG, Italy

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P.O. San Camillo De Lellis

Rieti, RI, Italy

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Ospedali Riuniti Albano-Genzano

Albano Laziale, RM, Italy

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Ospedale Civile San Paolo

Civitavecchia, RM, Italy

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Ospedale Generale Zona Parodi Delfino

Colleferro, RM, Italy

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Ospedale San Sebastiano Martire

Frascati, RM, Italy

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Ospedale San Giuseppe

Marino, RM, Italy

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Ospedale di Monterotondo

Monterotondo, RM, Italy

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Campus Biomedico

Roma, RM, Italy

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Ospedale San Filippo Neri

Roma, RM, Italy

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Ospedale Sant'Eugenio

Roma, RM, Italy

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Ospedale C. Forlanini

Roma, RM, Italy

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Ospedale San Camillo

Roma, RM, Italy

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Ospedale San Camillo

Roma, RM, Italy

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Ospedale Sandro Pertini

Roma, RM, Italy

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Policlinico Umberto Primo

Roma, RM, Italy

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Ospedale San Carlo di Nancy

Roma, RM, Italy

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Presidio Ospedaliero Villa Betania

Roma, RM, Italy

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Ospedale Generale di Zona "Cristo Re"

Roma, RM, Italy

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Ospedale Fatebenefratelli

Roma, RM, Italy

Site Status

Policlinico Agostino Gemelli

Roma, RM, Italy

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I.N.R.C.A.

Roma, RM, Italy

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Ospedale Santo Spirito

Roma, RM, Italy

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Ospedale A. Angelucci

Subiaco, RM, Italy

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Ospedale San Giovanni Evangelista

Tivoli, RM, Italy

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Ospedale Civile

Velletri, RM, Italy

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Ospedale G. Ceccarini

Riccione, RN, Italy

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Ospedale Infermi

Rimini, RN, Italy

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Ospedale Civile

Adria, RO, Italy

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Presidio Ospedaliero

Rovigo, RO, Italy

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Presidio Ospedaliero S.Maria della Speranza

Battipaglia, SA, Italy

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Ospedale G. Fucito

Mercato San Severino, SA, Italy

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Ospedale Civile

Nocera Inferiore, SA, Italy

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Ospedale San Francesco D'Assisi

Oliveto Citra, SA, Italy

Site Status

A.O. S.Giovanni di Dio e Ruggi di Aragona

Salerno, SA, Italy

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Ospedale dell'Immacolata

Sapri, SA, Italy

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Scafati, SA, Italy

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Ospedale San Luca

Vallo della Lucania, SA, Italy

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Presidio Ospedaliero Valdichiana Senese

Montepulciano, SI, Italy

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Poggibonsi, SI, Italy

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Policlinico Santa Maria alle Scotte

Siena, SI, Italy

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Morbegno, SO, Italy

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Sondalo, SO, Italy

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Sondrio, SO, Italy

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La Spezia, SP, Italy

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Sarzana - Loc. Santa Caterina, SP, Italy

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Azienda Ospedaliera Umberto I

Syracuse, SR, Italy

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Az. Ospedaliero Universitaria di Sassari

Sassari, SS, Italy

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Ospedale Civile

Thiesi, SS, Italy

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Ospedale Civile

Castellaneta, TA, Italy

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Presidio Ospedaliero della Valle D'Itria

Martina Franca, TA, Italy

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Ospedale Umberto I

Mottola, TA, Italy

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Ospedale S. Giuseppe Moscati

Taranto, TA, Italy

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Ospedale SS. Annunziata

Taranto, TA, Italy

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Ospedale Civile G. Mazzini

Teramo, TE, Italy

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Ospedale Alto Garda e Ledro

Arco, TN, Italy

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Casa di Cura Villa Bianca

Trento, TN, Italy

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Ospedale Santa Croce

Moncalieri, To, Italy

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Ospedale San Luigi Gonzaga

Orbassano, TO, Italy

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Ospedale Civile E. Agnelli

Pinerolo, TO, Italy

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Susa, TO, Italy

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Ospedale Evangelico Valdese

Torino, TO, Italy

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Ospedale Martini

Torino, TO, Italy

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Ospedale Maria Vittoria

Torino, TO, Italy

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Torino, TO, Italy

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Ospedale Civile Vittorio Emanuele II

Castelvetrano, TP, Italy

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Ospedale Civile Sant'Antonio Abate

Erice, TP, Italy

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Ospedale A. Ajello

Mazara del Vallo, TP, Italy

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Azienda USL 4 Terni

Terni, TR, Italy

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Azienda Ospedaliera - Univ. Ospedali Riuniti

Trieste, TS, Italy

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Ospedale De Gironcoli

Conegliano Veneto, TV, Italy

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Ospedale Santa Maria dei Battuti

Conegliano Veneto, TV, Italy

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Ospedale Ca' Foncello

Treviso, TV, Italy

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Ospedale di Ialmicco - Palmanova - Udine

Palmanova, UD, Italy

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Ospedale S. Antonio

San Daniele del Friuli, UD, Italy

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Ospedale Civile Sant'Antonio Abate

Tolmezzo, UD, Italy

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Santa Maria della Misericordia

Udine, UD, Italy

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Ospedale S. Antonio Abate

Gallarate, VA, Italy

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Presidio Ospedaliero

Saronno, VA, Italy

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Ospedale di Circolo A. Bellini

Somma Lombardo, VA, Italy

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Fondazione S. Maugeri Clinica del Lavoro

Tradate, VA, Italy

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Azienda Ospedaliera e Universitaria

Varese, VA, Italy

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Ospedale del Ponte

Varese, VA, Italy

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Ospedale Castelli

Verbania, VB, Italy

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Ospedale Civile

Dolo, VE, Italy

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Ospedale Civile Umberto I

Mestre, VE, Italy

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Ospedale Civile

Mirano, VE, Italy

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Ospedale Civile

Portogruaro, VE, Italy

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Ospedali Civili Riuniti

Venezia, VE, Italy

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Noventa Vicentina, VI, Italy

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Ospedale Civile San Biagio

Bovolone, VR, Italy

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Ospedale Mater Salutis

Legnago, VR, Italy

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Ospedale Sacro Cuore

Negrar, VR, Italy

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Ospedale G. Fra Castoro

San Bonifacio, VR, Italy

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Azienda Ospedaliera

Verona, VR, Italy

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Ospedale di Villafranca

Villafranca di Verona, VR, Italy

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Presidio Ospedaliero

Soriano Calabro, VV, Italy

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Ospedale Civile G. Jazzolino

Vibo Valentia, VV, Italy

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Ospedale SS. Trinita'

Borgomanero, , Italy

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Ospedale Civile di Boscotrecase

Boscotrecase, , Italy

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Opsedale San Leonardo

Castellammare di Stabia, , Italy

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Ospedale Civile San Giovanni di Dio

Frattaminore, , Italy

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Ospedale Generale di Zona

Giugliano in Campania, , Italy

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MIOspedale San Raffaele

Milan, , Italy

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AORN Cardarelli

Napoli, , Italy

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Azienda Ospedaliera Vincenzo Monaldi

Napoli, , Italy

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Fondazione Pascale

Napoli, , Italy

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Ospedale Domenico Cotugno

Napoli, , Italy

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Policlinico Universitario Federico II

Napoli, , Italy

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Pres.Ospedaliero S. Maria della Pieta'

Nola, , Italy

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Ospedale Santa Maria delle Grazie

Pozzuoli, , Italy

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Ospedale Santa Maria della Misericordia

Sorrento, , Italy

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Fondazione Salvatore Maugeri

Veruno, , Italy

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Cardiocentro Ticino

Lugano, , Switzerland

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Italy Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Tavazzi L, Tognoni G, Franzosi MG, Latini R, Maggioni AP, Marchioli R, Nicolosi GL, Porcu M; GISSI-HF Investigators. Rationale and design of the GISSI heart failure trial: a large trial to assess the effects of n-3 polyunsaturated fatty acids and rosuvastatin in symptomatic congestive heart failure. Eur J Heart Fail. 2004 Aug;6(5):635-41. doi: 10.1016/j.ejheart.2004.03.001.

Reference Type BACKGROUND
PMID: 15302013 (View on PubMed)

Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni G; Gissi-HF Investigators. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Oct 4;372(9645):1223-30. doi: 10.1016/S0140-6736(08)61239-8. Epub 2008 Aug 29.

Reference Type RESULT
PMID: 18757090 (View on PubMed)

Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni G; Gissi-HF Investigators. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Oct 4;372(9645):1231-9. doi: 10.1016/S0140-6736(08)61240-4. Epub 2008 Aug 29.

Reference Type RESULT
PMID: 18757089 (View on PubMed)

Canepa M, Ameri P, Lucci D, Nicolosi GL, Marchioli R, Porcu M, Tognoni G, Franzosi MG, Latini R, Maseri A, Tavazzi L, Maggioni AP; GISSI-HF Investigators. Modes of death and prognostic outliers in chronic heart failure. Am Heart J. 2019 Feb;208:100-109. doi: 10.1016/j.ahj.2018.11.009. Epub 2018 Nov 24.

Reference Type DERIVED
PMID: 30580128 (View on PubMed)

Mantovani A, Targher G, Temporelli PL, Lucci D, Gonzini L, Nicolosi GL, Marchioli R, Tognoni G, Latini R, Cosmi F, Tavazzi L, Maggioni AP; GISSI-HF Investigators. Prognostic impact of elevated serum uric acid levels on long-term outcomes in patients with chronic heart failure: A post-hoc analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) trial. Metabolism. 2018 Jun;83:205-215. doi: 10.1016/j.metabol.2018.02.007. Epub 2018 Mar 29.

Reference Type DERIVED
PMID: 29477817 (View on PubMed)

Dauriz M, Targher G, Temporelli PL, Lucci D, Gonzini L, Nicolosi GL, Marchioli R, Tognoni G, Latini R, Cosmi F, Tavazzi L, Maggioni AP; GISSI-HF Investigators. Prognostic Impact of Diabetes and Prediabetes on Survival Outcomes in Patients With Chronic Heart Failure: A Post-Hoc Analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) Trial. J Am Heart Assoc. 2017 Jul 5;6(7):e005156. doi: 10.1161/JAHA.116.005156.

Reference Type DERIVED
PMID: 28679559 (View on PubMed)

Rossi A, Inciardi RM, Rossi A, Temporelli PL, Lucci D, Gonzini L, Marchioli R, Nicolosi GL, Tavazzi L; GISSI-HF Investigators. Prognostic effects of rosuvastatin in patients with co-existing chronic obstructive pulmonary disease and chronic heart failure: A sub-analysis of GISSI-HF trial. Pulm Pharmacol Ther. 2017 Jun;44:16-23. doi: 10.1016/j.pupt.2017.03.001. Epub 2017 Mar 3.

Reference Type DERIVED
PMID: 28263812 (View on PubMed)

Florea VG, Rector TS, Anand IS, Cohn JN. Heart Failure With Improved Ejection Fraction: Clinical Characteristics, Correlates of Recovery, and Survival: Results From the Valsartan Heart Failure Trial. Circ Heart Fail. 2016 Jul;9(7):e003123. doi: 10.1161/CIRCHEARTFAILURE.116.003123.

Reference Type DERIVED
PMID: 27413037 (View on PubMed)

Damman K, Masson S, Hillege HL, Voors AA, van Veldhuisen DJ, Rossignol P, Proietti G, Barbuzzi S, Nicolosi GL, Tavazzi L, Maggioni AP, Latini R. Tubular damage and worsening renal function in chronic heart failure. JACC Heart Fail. 2013 Oct;1(5):417-24. doi: 10.1016/j.jchf.2013.05.007. Epub 2013 Sep 11.

Reference Type DERIVED
PMID: 24621973 (View on PubMed)

Barlera S, Tavazzi L, Franzosi MG, Marchioli R, Raimondi E, Masson S, Urso R, Lucci D, Nicolosi GL, Maggioni AP, Tognoni G; GISSI-HF Investigators. Predictors of mortality in 6975 patients with chronic heart failure in the Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico-Heart Failure trial: proposal for a nomogram. Circ Heart Fail. 2013 Jan;6(1):31-9. doi: 10.1161/CIRCHEARTFAILURE.112.967828. Epub 2012 Nov 14.

Reference Type DERIVED
PMID: 23152490 (View on PubMed)

La Rovere MT, Pinna GD, Maestri R, Barlera S, Bernardinangeli M, Veniani M, Nicolosi GL, Marchioli R, Tavazzi L; GISSI-HF Investigators. Autonomic markers and cardiovascular and arrhythmic events in heart failure patients: still a place in prognostication? Data from the GISSI-HF trial. Eur J Heart Fail. 2012 Dec;14(12):1410-9. doi: 10.1093/eurjhf/hfs126. Epub 2012 Jul 30.

Reference Type DERIVED
PMID: 22851700 (View on PubMed)

Latini R, Gullestad L, Masson S, Nymo SH, Ueland T, Cuccovillo I, Vardal M, Bottazzi B, Mantovani A, Lucci D, Masuda N, Sudo Y, Wikstrand J, Tognoni G, Aukrust P, Tavazzi L; Investigators of the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) and GISSI-Heart Failure (GISSI-HF) trials. Pentraxin-3 in chronic heart failure: the CORONA and GISSI-HF trials. Eur J Heart Fail. 2012 Sep;14(9):992-9. doi: 10.1093/eurjhf/hfs092. Epub 2012 Jun 27.

Reference Type DERIVED
PMID: 22740508 (View on PubMed)

Masson S, Anand I, Favero C, Barlera S, Vago T, Bertocchi F, Maggioni AP, Tavazzi L, Tognoni G, Cohn JN, Latini R; Valsartan Heart Failure Trial (Val-HeFT) and Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca-Heart Failure (GISSI-HF) Investigators. Serial measurement of cardiac troponin T using a highly sensitive assay in patients with chronic heart failure: data from 2 large randomized clinical trials. Circulation. 2012 Jan 17;125(2):280-8. doi: 10.1161/CIRCULATIONAHA.111.044149. Epub 2011 Dec 2.

Reference Type DERIVED
PMID: 22139751 (View on PubMed)

Damman K, Masson S, Hillege HL, Maggioni AP, Voors AA, Opasich C, van Veldhuisen DJ, Montagna L, Cosmi F, Tognoni G, Tavazzi L, Latini R. Clinical outcome of renal tubular damage in chronic heart failure. Eur Heart J. 2011 Nov;32(21):2705-12. doi: 10.1093/eurheartj/ehr190. Epub 2011 Jun 11.

Reference Type DERIVED
PMID: 21666249 (View on PubMed)

Finzi AA, Latini R, Barlera S, Rossi MG, Ruggeri A, Mezzani A, Favero C, Franzosi MG, Serra D, Lucci D, Bianchini F, Bernasconi R, Maggioni AP, Nicolosi G, Porcu M, Tognoni G, Tavazzi L, Marchioli R. Effects of n-3 polyunsaturated fatty acids on malignant ventricular arrhythmias in patients with chronic heart failure and implantable cardioverter-defibrillators: A substudy of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca (GISSI-HF) trial. Am Heart J. 2011 Feb;161(2):338-343.e1. doi: 10.1016/j.ahj.2010.10.032.

Reference Type DERIVED
PMID: 21315217 (View on PubMed)

Maggioni AP, Fabbri G, Lucci D, Marchioli R, Franzosi MG, Latini R, Nicolosi GL, Porcu M, Cosmi F, Stefanelli S, Tognoni G, Tavazzi L; GISSI-HF Investigators. Effects of rosuvastatin on atrial fibrillation occurrence: ancillary results of the GISSI-HF trial. Eur Heart J. 2009 Oct;30(19):2327-36. doi: 10.1093/eurheartj/ehp357. Epub 2009 Aug 30.

Reference Type DERIVED
PMID: 19717850 (View on PubMed)

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G105

Identifier Type: -

Identifier Source: org_study_id

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